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NCT03430011 · OUTCOME

Number of Participants With Clinically Significant Laboratory Abnormalities by Severity in Phase 1 and Phase 1 Anakinra

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-05-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)

What was measured

Clinically significant laboratory abnormalities are assessed by investigator and are reported as treatment-emergent adverse event (TEAE). TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment is not considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening.

Analysis population: All participants who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) in phase 1 and in phase 1 Anakinra

Groups in this outcome

Phase 1 50 x 10^6 Cells

JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 150 x 10^6 Cells

JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 300 x 10^6 Cells

JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 450 x 10^6 Cells

JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 600 x 10^6 Cells

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 Anakinra 600 x 10^6 Cells

2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1 50 x 10^6 Cells14
Phase 1 150 x 10^6 Cells30
Phase 1 300 x 10^6 Cells26
Phase 1 450 x 10^6 Cells21
Phase 1 600 x 10^6 Cells20
Phase 1 Anakinra 600 x 10^6 Cells14

Reported measurements

Neutropenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Neutropenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells10Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells28Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells22Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells20Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells17Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells10Not reportedNot reportedNot reportedNot reported
Anemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells9Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells19Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells16Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells11Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells13Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells10Not reportedNot reportedNot reportedNot reported
Thrombocytopenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Thrombocytopenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells15Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells11Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells12Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells11Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells5Not reportedNot reportedNot reportedNot reported
Leukopenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Leukopenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells8Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells12Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells7Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Lymphopenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells4Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Lymphopenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Febrile neutropenia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells7Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Febrile neutropenia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Haemolysis grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Hypofibrinogenaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Hypophosphataemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells5Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells6Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells6Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells6Not reportedNot reportedNot reportedNot reported
Hypophosphataemia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Hypocalcaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Hypocalcaemia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Hypokalaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells3Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Hyponatraemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Hypomagnesaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Hyperglycaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Hyperglycaemia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Hypoalbuminaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Hypertriglyceridaemia grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Hypertriglyceridaemia grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells2Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Blood alkaline phosphatase increased grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Serum ferritin increased grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 50 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 150 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 300 x 10^6 Cells1Not reportedNot reportedNot reportedNot reported
Phase 1 450 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 Anakinra 600 x 10^6 Cells0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
    title
    Neutropenia grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        28
      3. group Id
        OG002
        value
        22
      4. group Id
        OG003
        value
        20
      5. group Id
        OG004
        value
        17
      6. group Id
        OG005
        value
        10
    title
    Neutropenia grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        13
      6. group Id
        OG005
        value
        10
    title
    Anemia grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        4
    title
    Thrombocytopenia grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        11
      6. group Id
        OG005
        value
        5
    title
    Thrombocytopenia grade 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        0
    title
    Leukopenia grade 3
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        4
    title
    Leukopenia grade 4
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
    title
    Lymphopenia grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    Lymphopenia grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Febrile neutropenia grade 3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Febrile neutropenia grade 4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    Haemolysis grade 3
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      26
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      20
    6. group Id
      OG005
      value
      14
    units
    Participants
description
Clinically significant laboratory abnormalities are assessed by investigator and are reported as treatment-emergent adverse event (TEAE). TEAE is defined as an AE that starts any time from initiation of JCARH125 administration through and including 90 days following the JCARH125 infusion graded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Any AE occurring after the initiation of another anticancer treatment is not considered a TEAE. Grade 3=Severe; Grade 4=Life-threatening.
groups
  1. description
    JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
    id
    OG000
    title
    Phase 1 50 x 10^6 Cells
  2. description
    JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
    id
    OG001
    title
    Phase 1 150 x 10^6 Cells
  3. description
    JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
    id
    OG002
    title
    Phase 1 300 x 10^6 Cells
  4. description
    JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
    id
    OG003
    title
    Phase 1 450 x 10^6 Cells
  5. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    OG004
    title
    Phase 1 600 x 10^6 Cells
  6. description
    2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    OG005
    title
    Phase 1 Anakinra 600 x 10^6 Cells
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one infusion of JCARH125 (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) in phase 1 and in phase 1 Anakinra
reporting Status
POSTED
time Frame
From the time of JCARH125 infusion to 90 days following the infusion (Up to 90 days)
title
Number of Participants With Clinically Significant Laboratory Abnormalities by Severity in Phase 1 and Phase 1 Anakinra
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice